Attorney:
Richard D. Kelly
May 16, 2022
Congress sought to keep Patent Office delays from prejudicing a patentee by granting PTA to compensate for the Patent Office delays. While one might expect the Patent Office to work mightily to avoid administrative delays in prosecution, today the average time to first action is about 17 months, three months longer than the target of 14 months adding on average 3 months to the patent term. Other delays during prosecution add still more time to the PTA period. Since these are averages, the additional time can be significant. In pharmaceuticals the PTA added for delays of even a few months can mean hundreds of millions of dollars in revenue. The two district courts have addressed this issue where an ODP defense is raised against the later expiring patent because of PTA and came to different conclusions. See Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc., 533 F. Supp. 3d 170 (D.N.J. 2021) (the judicially created ODP does not trump the statutory PTA) and Mitsubishi. Magna Elecs., Inc. v. TRW Automotive Holdings Corp., No. 12-cv-654, 2015 WL 11430786 (W.D. Mich. Dec. 10, 2015) (ODP trumps PTA).<... Read more
January 25, 2022
Conclusion
Okay, let’s get this out of the way up front. The answer is maybe… but only with a lot more work and with substantially reduced claim scope.<... Read more
Attorney:
Elissa Sanford
December 13, 2021
On Dec. 1, 2021, the Federal Circuit held that Moderna lacked standing in an appeal from a Patent Trial and Appeal Board (“PTAB”) decision against rival Arbutus where the PTAB determined U.S. Patent No. 9,364,435 (“the ’435 patent”) was not unpatentable as obvious.[1] The ’435 patent concerns vaccine delivery technology, particularly a lipid nanoparticle delivery system used to protect nucleic acids delivered to cells as utilized in vaccines including Moderna’s COVID-19 vaccine.<... Read more
Attorney:
Jeffrey B. McIntyre
December 1, 2021
Yesterday, in Biogen v. Mylan, the Federal Circuit ruled that claims in Biogen’s U.S. patent 8,399,514 (the ’514 patent) were invalid under 35 U.S.C. §112 for failing to satisfy the written description requirement. The Federal Circuit upheld the district court’s previous invalidity determination.<... Read more
Attorney:
J. Derek Mason, Ph.D., CLP
September 22, 2021
In a purported effort to lower drug prices, the Department of Health and Human Services (HHS) recently released a proposed plan calling for the US Food and Drug Administration (FDA) to work with the US Patent and Trademark Office (USPTO), suggesting that such collaboration would “facilitate greater awareness of their complementary work and introduce efficiency into their respective workstreams.” This is only one part of the proposed plan, the other parts of which are not the focus of this post.<... Read more
Attorney:
Richard D. Kelly
August 9, 2021
This week saw two cases reported with possible implications for skinny labels. The first was a recommendation be Magistrate Judge Hall, District of Delaware, that Hikma Pharmaceuticals could not dodge Amarin’s lawsuit claiming Hikma induced infringement of Amarin’s patents on the use of its heart drug Vascepa® . The patents in suit are U.S. Patent Nos. 9,700,537 (the ’537 patent), 8,642,077 (the ’077 patent), and 10,568,861 (the ’861 patent) under 35 U.S.C. § 271(b). In an interesting twist, Amarin also sued Health Net, an insurance provider, for also inducing infringement of the same patents. The suit against Health Net appears to be a first where an insurance company was sued for inducing infringement of method of using a drug.<... Read more
Attorney:
Grace Kim
July 15, 2021
In the recent decision PacificBiosciences of California, Inc. v. Oxford Nanopore Techs., Inc., No. 20-2155 issued on May 11, 2021, the Federal Circuit affirmed the district court’s holdings on two important issues, which are particularly of present-day relevance: (1) the influence of the global COVID-19 crisis on the public or jury’s view of the enforcement of intellectual property; and (2) the question of enablement.<... Read more
Attorney:
Elissa Sanford
May 20, 2021
Recent litigation, including the Federal Circuit decision in Amgen v. Sanofi, has created concern among biologics manufacturers with regard to whether their existing intellectual property will remain protected, and whether they will be able to secure patents for future drugs. The uncertainty surrounding the patentability of biologics has led the industry to search for potential alternatives to patent protection. One such alternative could lead to pharmaceutical companies leaning on the exclusivity granted by the U.S. Food and Drug Administration ("FDA") as a way to avoid the patent route entirely. Where patents are a property right granted by the United States any time during the development of a drug, FDA exclusivity attaches upon approval of the drug and grants certain delays and prohibitions on the approval of competitor drugs. Biologics are covered by a considerably longer exclusivity period than other drug types, usually with 12 years total of market protection, as delineated by the Biologics Price Competition and Innovation Act ("BPCIA").... Read more
Attorney:
Richard D. Kelly
May 4, 2021
On April 23 President Biden signed into law changes narrowing the scope of eligibility for the non-patent “new chemical entity” (NCE) 5-year exclusivity provisions of 21 U.S.C. §301 et seq. The 5-year exclusivity comprises a 4-year data exclusivity provision during which time a generic applicant cannot rely on the drug application to establish either safety or efficacy which is followed by a 1-year marketing exclusivity. The exclusivity provision found in 21 U.S.C. § 355 (c)(3)(E)(ii) prior to the amendment described the NCE as applying to a drug where “no active ingredient” has been previously approved under § 355. Active ingredient is defined in 21 § 314.3(b) as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease ….” Some drugs become active only after being metabolized to what is called the active moiety. Prodrugs are an example of this phenomenon. Under the prior definition both a prodrug which metabolized into the active drug and the metabolite might each be capable of receiving separate NCE status.<... Read more
Attorney:
Grace Kim
April 21, 2021
I recently wrote an article (NHK-Fintiv Rule Challenges Look Futile at Federal Circuit) about a Federal Circuit decision that dismissed Mylan’s appeal of a PTAB decision that denied institution of an IPR. The Federal Circuit concluded that although judicial review is available by petition for mandamus and the Federal Circuit may consider Mylan’s request for mandamus, “there is no reviewability of the Director’s exercise of his discretion to deny institution except for colorable constitutional claims.” Mylan Laboratories Ltd. v. Janssen Pharmaceutica. N.V., No. 2021-1071, slip op. at 12 (Fed. Cir. March 12, 2021) (precedential).<... Read more